MS&T Process Scientist – Drug Product

Work at ROCKET PHARMA and help cure rare diseases!

Rocket Pharma is a fully-integrated, clinical-stage company advancing gene therapies with curative potential for multiple rare childhood diseases. Rocket places enormous value on people and considers team member progress and well-being to be as important as the progress of its pipeline. We are looking for hands-on team players who enjoy collaborating with colleagues.  We share a passion for seeking gene therapy cures for devastating diseases and making a difference for patients. This is an opportunity to become an integral part of a small, highly productive team and to help grow an entrepreneurial, scientifically driven organization that is increasingly recognized as a leading biotechnology innovator. In addition to a competitive compensation package featuring a generous 401K match and stock options, the position includes excellent health benefits.

Build. Test. Perfect. Execute. Repeat. 

Gene and cell therapy is all about delivery. Creating, testing, fine-tuning, and perfecting a replicable process to manufacture vector and drug products at optimal genetic payloads can turn hope into reality for patients. The heart of Rocket’s in-house manufacturing investment is not its 100,000 square-foot state-of-the-art facility, but the talented people building it, creating and nurturing the processes within, and scaling up to meet the needs of an expanding homegrown pipeline. The Rocket Manufacturing Team works with the end goal in mind: innovate to meet commercial needs – not the next cohort of patients…and it’s the only team in biotech doing it on both AAV and LV platforms.

Position Summary:

We are seeking a motivated MS&T Process Scientist – Drug Product who will be responsible for oversight and management of external contract manufacturing organization (CMO) and contract testing organization (CTO) stakeholders enabling GMP manufacturing of lentivirus drug product production. The ideal applicant will have a strong background in cell and gene therapy manufacturing and the associated analytics for in-process characterization and drug product testing. The position will also support platform-focused drug product projects requiring technology development and platform optimization. The incumbent will collaborate with cross-functional department colleagues working within Rocket Pharma and other partners to ensure the successful execution of Rocket Pharma’s company business strategies and company objectives.

Primary Responsibilities:

• Oversee successful lentivirus drug product manufacture at contract manufacturing organizations (CMOs) and timely release by contract testing organizations (CTOs)
• Build and maintain positive professional relationships with key CMO stakeholders.
• Provide operational and technical oversight before and during manufacturing campaigns to ensure successful execution and real-time issue resolution.
• Review executed batch records and other production-related documents to ensure conformance and facilitate the timely release of ex vivo lentivirus drug product.
• Collaborate with CMO to ensure process scalability, with process monitoring and analysis, review CMO generated campaign summary reports, draft regulatory documents and recommend improvements in MS&T practices
• Provide technical support to Manufacturing execution, deviation investigation, Corrective Action Prevention Plans (CAPAs), and necessary change controls.
• Support FMEA-based risk assessment to enable Process Characterization and Process Performance Qualification, Control Strategy development, product launch, and lifecycle management.

Education/Experience and Skills Requirements:

• B.S/M.S in Pharmaceutical, Biological or Bioengineering Sciences with 5-7 years of hands-on manufacturing experience in Process Development, MS&T or Manufacturing in Biotech/biopharmaceutical industry. Experience with Cell Gene Therapy a plus.
• Working understanding of viral vector-based analytical methods to characterize lentivirus drug products and US/EU regulatory requirements is a plus.
• Demonstrated understanding of the fundamentals of ICH and industrial guidelines as apply to CMC development and lifecycle management.
• Familiar with FMEA-based risk assessment, and support Process Characterization and PPQ design and execution
• Working knowledge of statistical methods for DoE design, statistical process control (SPC), multivariate analysis (MVA), and/or process analytical technologies (PAT) techniques for drug product commercialization.
• Experience with working in an outsourcing model, CDMO management, and in a highly matrixed organization. Cross-functional experience in Quality Assurance, Regulatory Affairs, and R&D are desirable.
• Comfortable in a fast-paced environment with the ability to handle rapidly changing information.

Desired Competencies:

• Ability to develop and execute strategies
• Handle issues appropriately and with a sense of urgency
• Strong leadership to support a multi-project environment in an industry setting.
• Ability to interact, cooperate and motivate across departments and functions.

Physical/Mental Requirements:

• Ability to stand/sit for up to 8 hours

A diverse workforce fosters innovation and strengthens Rocket’s business. We ensure equal opportunity without discrimination or harassment in the workplace on the basis of gender, race, color, religion, national origin, age, physical or mental disability, pregnancy, citizenship, status as a protected veteran, marital status, sexual orientation, gender identity and expression, genetic information, or any other characteristic protected by applicable local, state, and federal laws.